Regulatory Compliance & Quality Standards Flashcards
6 cards from real CAPA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Regulatory Compliance & Quality Standards flashcards as text
What is the purpose of regulatory compliance in the CAPA process?
Answer: To meet legal and industry requirements
Regulatory compliance ensures that the organization adheres to laws, regulations, and standards that govern its operations.
Which regulatory body oversees CAPA requirements for medical devices in the U.S.?
Answer: FDA
The FDA sets CAPA requirements as part of the Quality System Regulation (QSR) for medical device manufacturers.
What does ISO 13485 focus on?
Answer: Medical device quality management systems
ISO 13485 is an international standard that outlines quality management system requirements for medical devices.
Which of the following is a benefit of aligning with quality standards?
Answer: Improved quality and reduced risk
Aligning with quality standards helps improve product quality, increase customer satisfaction, and reduce compliance risks.
What is the role of documentation in compliance with quality standards?
Answer: To demonstrate compliance and traceability
Documentation ensures traceability, consistency, and provides evidence of compliance during audits.
How can organizations ensure ongoing compliance with evolving standards?
Answer: Conduct internal audits and training
Regular training and internal audits help organizations stay updated and continually improve their compliance efforts.
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